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Table 3 Outcome measures, assessment instruments, and assessment time points

From: A clinical trial of group-based body psychotherapy to improve bodily disturbances in post-treatment cancer patients in combination with randomized controlled smartphone-triggered bodily interventions (KPTK): study protocol

Measures

Assessment instruments

Baseline Assessment T0

Pre-Intervention Assessment T1

Weekly assessments after group BPT

Pre/Post smartphone-triggered intervention

Post-Intervention Assessment T2

Social demographics

Sociodemographic variables (sex, age, marital status, educational level, and job-related situation)

X

    

Psychosocial health

Basic Documentation for Psycho-Oncology (PO-Bado)

X

    

Performance status

Performance status score of the Eastern Cooperative Oncology Group (ECOG)

X

    

Bodily disturbances

Body Image Scale (BIS)

X

X

X

 

X

Awareness of bodily changes due to the diagnosis and treatment

single item; VAS-A patient-assessed (range 0–10)

X

X

  

X

Distress caused by bodily changes

single item; VAS-B patient-assessed (range 0–10)

X

X

  

X

Body mindfulness

Body Mindfulness Questionnaire (BMQ)

X

X

X

 

X

Distress

National Comprehensive Cancer Network Distress Thermometer (DT)

X

X

 

X

X

Somatic Symptoms

Somatic Symptom Disorder-B Criteria Scale (SSD-12)

X

X

  

X

Quality of life

EORTC QLQ-C30

X

X

  

X

Vitality

36-Item Short Form Health Survey (SF-36) – Scale Vitality

X

X

  

X

Mental health

36-Item Short Form Health Survey (SF-36) – Scale Mental Health

X

X

  

X

Anxiety and depression

Hospital Anxiety and Depression Scale (HADS)

X

X

  

X

Suicidal tendency

Beck Depression Inventory (BDI-II), Item I: Suicidal tendency

X

X

  

X

Group cohesion

Group Climate Questionnaire – Short Form (GCQ-S)

  

X

 

X

Mood

Multidimensional Mood Questionnaire (MDMQ)

   

X

 

Experience of presence

single item; VAS (range 0–10)

   

X

 

Experience of vitality

single item; VAS (range 0–10)

   

X

 

Therapist’s rating of patient’s bodily changes due to the diagnosis and treatment

Semi-standardized Interview single item; VAS-A therapist-assessed (range 0–10)

X

    

Therapist’s rating of patient’s distress caused by bodily changes

Semi-standardized Interview single item; VAS-B therapist-assessed (range, 0–10)

X

    

Motivation, previous experience, eligibility

Semi-standardized Interview

X

    

Acceptance, treatment effect, potential for improvement, safety aspects

Semi-standardized Interview

    

X

Therapist’s adherence to the manual

Adapted checklist to session content (see Table 2.)

  

X

  
  1. BPT Body Psychotherapy, EORTC QLQ-C30 European Organization for Research and Treatment of Cancer QLQ-C30, VAS Visual Analog Scale